Evaluation of PENG Block in Terms of Block Time and Postoperative Pain

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06132308
Collaborator
(none)
60
1
3
23.5
2.6

Study Details

Study Description

Brief Summary

Hip fracture is a common orthopedic emergency in the elderly and causes significant morbidity and is associated with mortality. In most patients, surgical reduction and fixation is the definitive treatment. Effective perioperative analgesia minimizing the need for opioids and related side effects is recommended in this patient population. Therefore, various methods are used. When the investigators look at the literature, for PENG block It is observed that different drug doses (20cc, 30cc, and 40cc) are used. In this study, the investigators planned to investigate the effectiveness of PENG blocks, postoperative analgesia, and side effects.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PENG Block with 0.25% bupivacaine
N/A

Detailed Description

Patients in the ASA 1-3 group who had hip surgery with PENG block for any reason will be included in the study. Approximately 60 patients will participate in the study, the number will be finalized as a result of power analysis. The routine algorithm for patients who will undergo hip surgery is spinal or general anesthesia after peripheral block for postoperative analgesia. Before the block, all patients were monitored by standard monitoring and intravenous vascular access was opened. For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and local anesthetic is administered by intermittent aspiration. Although drug doses vary according to the patient and the surgery to be performed in our clinic, %0.25 bupivacaine is used in 20cc, 30cc and 40cc doses. In all patients with block, 30 minutes after the block application, motor and sensory examination is carried out. Sensory block was evaluated by cold stimulus (0 = no cold sensation, 1 = cold sensation severely reduced, 2 = cold sensation slightly decreased, 3 = normal cold sensation). In patients who will undergo hip surgery, due to limited kidney and liver reserves opioids are often used for analgesia. In our clinic, to reduce opioid use in this elderly patient group, preoperative nerve block method is used. Postoperative analgesic needs of the patients will be recorded from the information in the current patient controlled analgesia device. Demographic data of patients, surgical method and duration from the anesthesia form will be followed. Postoperative numerical evaluation scale (NRS-numeric rating scale; 0 = no pain, 10 = excruciating pain) will be recorded. Postoperative pain, muscle strength, block time and nausea-vomiting PACU, 4, 8, 24 hours will be recorded. Postoperative pain treatment satisfaction of patients numerically scale (NRS, 0 = dissatisfied, 10 = extremely satisfied) and postoperative first night sleep quality at 24 hours with NRS (0= could not sleep all night, 10= slept very well) query will be recorded.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Evaluation of PENG Block Applied in Hip Surgery in Terms of Block Duration and Postoperative Pain
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: PENG Block with 0.25% bupivacaine (20 cc)

For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 20cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.

Procedure: PENG Block with 0.25% bupivacaine
Peng block was performed.

Experimental: PENG Block with 0.25% bupivacaine (30 cc)

For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 30cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.

Procedure: PENG Block with 0.25% bupivacaine
Peng block was performed.

Experimental: PENG Block with 0.25% bupivacaine (40 cc)

For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 40cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.

Procedure: PENG Block with 0.25% bupivacaine
Peng block was performed.

Outcome Measures

Primary Outcome Measures

  1. The degree of postoperative pain [0 hour]

    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

  2. The degree of postoperative pain [4 hour]

    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

  3. The degree of postoperative pain [8 hour]

    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

  4. The degree of postoperative pain [24 hour]

    The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

Secondary Outcome Measures

  1. Postoperative tramadol consumption [0 hour]

    total tramadol consumption in three groups will be assessed in the postoperative period

  2. Postoperative tramadol consumption [4hour]

    total tramadol consumption in three groups will be assessed in the postoperative period

  3. Postoperative tramadol consumption [8 hour]

    total tramadol consumption in three groups will be assessed in the postoperative period

  4. Postoperative tramadol consumption [24 hour]

    total tramadol consumption in three groups will be assessed in the postoperative period

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who have undergone hip surgery with PENG block for any reason
Exclusion Criteria:
  • chronic opioid users

  • cognitive disorders

  • written consent form haven't get

  • history of relevant drug allergy

  • infection of the skin at the site of needle puncture area

  • coagulopathy

Contacts and Locations

Locations

Site City State Country Postal Code
1 university of health siences diskapi yildirim beyazit T&R hospital Ankara Turkey

Sponsors and Collaborators

  • Diskapi Yildirim Beyazit Education and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Savas Altinsoy, Assistant Professor, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT06132308
Other Study ID Numbers:
  • Diskapı-YB-SA-PENG
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Savas Altinsoy, Assistant Professor, Diskapi Yildirim Beyazit Education and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2023